Psycho-Babble Medication Thread 314102

Shown: posts 1 to 13 of 13. This is the beginning of the thread.

 

NEWS ON THE SELEGILINE PATCH!!!!!!!!!!!!!!!!!!!!!!

Posted by bipolarspectrum on February 16, 2004, at 13:11:21

Hi,
I have recently spoken to a pdoc who spoke to the pharmaceutical company producing selegiline transdermal patch and........ drum roll plz... he told me they expect the patch to be out in WEEKS.. thats right, weeks! Of course, he said this wasn't certain, but the company is currently very active in terms of developing the necessary production capacity! If this occurs, I don't want to hear anymore FDA bashin!!
I really hope I don't raise expectations unnecessarily, but I felt that I had to share this news with my fellow psychobabblers

 

Re: NEWS ON THE SELEGILINE PATCH!!!!!!!!!!!!!!!!!!!!!!

Posted by sailor on February 16, 2004, at 16:44:10

In reply to NEWS ON THE SELEGILINE PATCH!!!!!!!!!!!!!!!!!!!!!!, posted by bipolarspectrum on February 16, 2004, at 13:11:21

BPS--I hope your source is right. I'm also eagerly awaiting EMSAM approval, as I believe I'm a godd candidate for it. MY note of caution is not simply the FDA, but whatever other biased sources might be making unfounded predictions. The only (and latest, I believe) "news" about the issue was generated by WAtson Pharmaceuticals, and Mylan, who are both on the New York Stock Exchange. They know that there are investors out there looking for a potential windafall if EMSAM hits the market and becomes "first line" drug of choice for depression. Any positive statements from the companies have to be suspect due to their sensitivity to the stock market. I read somewhere else, that the average time a company spends in Phase IV, which they just began, is over a year. And there is speculation that other companies, especially the SSRI giants, will exert political influence (if that's possible) on the FDA to deny EMSAM. I'm not being pesimistic here, just trying to protect myself from disappointment if things don't go as predicted. Admittedly, your post has me a little excited, though, so I'm not immune to hearsay, even if a bit skeptical. Let's stay on the trail! Patience, Persistence. Regards, Sailor

 

Re: NEWS ON THE SELEGILINE PATCH!!!!!!!!!!!!!!!!!!!!!!

Posted by bipolarspectrum on February 16, 2004, at 21:23:22

In reply to Re: NEWS ON THE SELEGILINE PATCH!!!!!!!!!!!!!!!!!!!!!!, posted by sailor on February 16, 2004, at 16:44:10

sailor,
I forget to add information about my source.. The pdoc is a psychopharmacologist, very active in collaborations with the pharmaceutical companies... I really hope we see it before the summer is through!!
One question, doesn't Phase IV mean its publically available but still undergoing further investigation????

 

Re: NEWS ON THE SELEGILINE PATCH!!!!!!!!!!!!!!!!!!!!!!

Posted by lepus on February 16, 2004, at 22:13:03

In reply to Re: NEWS ON THE SELEGILINE PATCH!!!!!!!!!!!!!!!!!!!!!!, posted by bipolarspectrum on February 16, 2004, at 21:23:22

What is this MAOI targeted for? Is it good for depression with anxiety? Does anyone have any good links for studies on what the patch will be best at treating?

Thanks...

 

Re: NEWS ON THE SELEGILINE PATCH!!!!!!!!!!!!!!!!!!!!!!

Posted by sailor on February 17, 2004, at 12:45:46

In reply to Re: NEWS ON THE SELEGILINE PATCH!!!!!!!!!!!!!!!!!!!!!!, posted by lepus on February 16, 2004, at 22:13:03

Re: Patch Anticipation. After re-reading press releases, and a statement from Somerset's president (Somerset is the contracted producer for the patch), I'm still unclear about "final approval" and availability to the public. Dr. Sharoky (Pres. of Somerset) says: "we will work dilligently with the FDA on the specific additional requirements needed to obtain approval....) Feb. 2, 2004
For the poster asking about what the patch is for, it will be marketed primarily as a first line treatment for major depression. My guess is it will also be touted as appropriate for treatment resistant depression as well. This is a huge market, badly in need of new and more effective drug treatments. If the patch meets many peoples' expectations, this could be a big seller, with all the media hoopla that eventually follows. By the way, selegeline (l-deprenyl), is an MAOB inhibitor, which increases impulse propogation of dopamine and noradrenaline. Because of the transdermal delivery system, at low doses it does not cause the "cheese effect" which is a major drawback to oral forms of the drug. Undoubtedly, if found successful by patients and practitioners, it will be tried for numerous "off label" conditions as well, including the usual combination, augmentation addition of other psychotropics. I have a high personal stake in this new opportunity--I'm 57, and have suffered major depression for over 30 years, with varying success from drugs. It appears that my condition is worsening and getting more difficult to treat (a scary thought!). Right now I'm on 80mg/day Parnate with modest benefit. Bring on the patch!! Patience, Persistence. Regards, Sailor

 

Re: NEWS ON THE SELEGILINE PATCH!!!!!!!!!!!!!!!!!!!!!!

Posted by SuzyQ1 on February 20, 2004, at 0:40:08

In reply to Re: NEWS ON THE SELEGILINE PATCH!!!!!!!!!!!!!!!!!!!!!!, posted by sailor on February 17, 2004, at 12:45:46

Hi,

I found a couple of websites that have opposing information of the selegiline patch (Emsam), and the dietary precautions that normally have to be observed with MAO Inhibitors. I've been on Nardil for over 20 years and have had very good results with depression, panic disorder, and social anxiety disorder. The only problem is that I have developed a mild case of asthma, and can't take asthma medication with MAOI's. I got new hope when I read about the Selegiline patch which I pray will be approved by the FDA. My only problem is that I'm still not sure, from the literature I read on the internet, if a person still has to watch their diet and the drug interaction. I'm copying the links to these websites and ask what you think. The lead investigator on this new drug, Dr. J. Alexander Bodkin, M.D., says that because the patch bypasses the gut, there are no dietary interactions. Yet, I also read that the FDA will not approve it without a proper warning label about the diet. So I'm really confused. Here are the links:

http://www.medscape.com/viewarticle/448256

http://pn.psychiatryonline.org/cgi/content/full/37/23/43-a

http://forums.about.com/ab-depression/messages?msg=8866.9

http://www.psychiatrictimes.com/p011040.html

The last link has the information towards the bottom, so I copied it to this post to make it easier. It clearly describes the safety of this patch and the lack of interactions (food and drugs):

Investigating Innovations

With reversible monoamine oxidase-A inhibitor antidepressants such as moclobemide not yet available in the United States, there is interest in the selective monoamine oxidase-B inhibitor approved for Parkinson's disease, selegiline (Eldepryl), as a possible alternative for depression with less liability than the monoamine oxidase inhibitor antidepressants for hypertensive drug interactions. A transdermal delivery system for selegiline was investigated by manufacturer Somerset Pharmaceuticals to ascertain whether circumventing the "first-pass" hepatic metabolism of oral administration and delivering higher selegiline levels to the central nervous system also reduced potential for adverse interaction with co-administered pressor drugs or with dietary tyramine.

In the first safety study, 10 healthy volunteers received the selegiline transdermal system (STS) with 20 mg/20 cm2 alone and with pseudoephedrine (Sudafed) in increasing dosage over two weeks. Tolerance of the combination was ascertained through monitoring of vital signs, electrocardiograms (EKGs), physical examinations and clinical laboratory results. Administration of the STS alone had little effect on blood pressure or heart rate, while pseudoephedrine alone raised both. Addition of pseudoephedrine to steady-state administration of STS, however, caused minimal changes in the pressor response indicators; and there were no clinically meaningful changes in other monitored parameters.

In another manufacturer-sponsored safety study, 301 patients with major depression were randomized to receive either the STS or topical placebo over an eight-week period without dietary tyramine restrictions. Safety monitoring revealed adverse effects, most of mild to moderate intensity, in 82.6% of patients with the STS and 77.6% of those with placebo; a statistically insignificant difference. There were no statistically significant differences between the groups in vital signs, physical examination, laboratory or EKG.

A separately reported kinetics study indicated that the STS provided higher and more sustained selegiline blood levels than oral administration, with significantly less metabolite formation. The researchers concluded that the transdermal administration of selegiline is safe for adults with major depression, and they anticipate future trials of efficacy.

 

Re: NEWS ON THE SELEGILINE PATCH!!!!!!!!!!!!!!!!!!!!!!

Posted by SuzyQ1 on February 20, 2004, at 0:53:16

In reply to Re: NEWS ON THE SELEGILINE PATCH!!!!!!!!!!!!!!!!!!!!!!, posted by sailor on February 17, 2004, at 12:45:46

Hi,

Please ignore the 1st and 3rd links I listed in my previous post. I found that the first one won't open, and listed the third one by mistake from a page that I was reading at the time. It's too bad we can't revise a post after it's been submitted. Thank you.

 

Re: NEWS ON THE SELEGILINE PATCH!!!!!!!!!!!!!!!!!!!!!! » SuzyQ1

Posted by sb417 on February 20, 2004, at 1:06:36

In reply to Re: NEWS ON THE SELEGILINE PATCH!!!!!!!!!!!!!!!!!!!!!!, posted by SuzyQ1 on February 20, 2004, at 0:53:16

My doctor told me that if you stay below 5 or 10 mg, the dietary restrictions can be relaxed, but you MUST continue to follow all the usual restrictions as far as drug interactions. A friend of mine tried oral selegiline at 5 mg and had a hypertensive crisis after eating pizza, so I think you still have to be careful. If I were on low dose selegiline, I would continue to follow the MAOI dietary restrictions even if the drug company literature says it's not necessary. I've had too many psychopharmacologic crises over the years, and I'm not interested in tempting fate. Each of us responds individually to these meds, and I imagine that it's still possible for sensitive individuals to have a bad cheese reaction below 10 mg, just as my friend did.

 

Re: NEWS ON THE SELEGILINE PATCH!!!!!!!!!!!!!!!!!!!!!!

Posted by noa on February 20, 2004, at 17:10:41

In reply to Re: NEWS ON THE SELEGILINE PATCH!!!!!!!!!!!!!!!!!!!!!! » SuzyQ1, posted by sb417 on February 20, 2004, at 1:06:36

The problem is (or so I have read) that selegiline at low doses is effective for parkinsons but not for depression. At low doses it is selective for type B MAO sites, but above 10 mg, it is not selective and acts also on type A MAO sites in the body, including the gastrointestinal system. But supposedly the selectivity is very dose dependent and tyramine intake is only considered safe when taking it at 10 mg or less, but at these doses, it hasn't been found to do much for depression.

I think there is also the risk of serotonin syndrome if combining with other meds.

 

Re: NEWS ON THE SELEGILINE PATCH!!!!!!!!!!!!!!!!!! » noa

Posted by Emme on February 21, 2004, at 9:10:12

In reply to Re: NEWS ON THE SELEGILINE PATCH!!!!!!!!!!!!!!!!!!!!!!, posted by noa on February 20, 2004, at 17:10:41

> The problem is (or so I have read) that selegiline at low doses is effective for parkinsons but not for depression.

A low dose can help with depression for some people.

> it hasn't been found to do much for depression.

I think there've been one or two other people on the board who have found it helpful at low doses. Not perfect by any means, but at least useful. We're not in the majority I know, but hey, you never know until you try.

I'm eagerly watching for updates on the patch though.

Emme

 

Re: News on the Selgiline Patch » Emme

Posted by noa on February 22, 2004, at 10:27:42

In reply to Re: NEWS ON THE SELEGILINE PATCH!!!!!!!!!!!!!!!!!! » noa, posted by Emme on February 21, 2004, at 9:10:12

>I think there've been one or two other people on the board who have found it helpful at low doses.

That is good to hear.

>but hey, you never know until you try.

You're right--you do never know until you try. Andrew Solomon, author of "Noonday Demon" used the analogy of a game of darts. I think he was actually paraphrasing Chekhov, who had been describing overall medicine of his day. Solomon, of course, was using it to describe psyhcopharm.

And each of us, I think, has a different dart board configuration.

 

Re: NEWS ON THE SELEGILINE PATCH!!!!!!!!!!!!!!!!!!!!!! » noa

Posted by mrporter1 on February 22, 2004, at 14:49:07

In reply to Re: NEWS ON THE SELEGILINE PATCH!!!!!!!!!!!!!!!!!!!!!!, posted by noa on February 20, 2004, at 17:10:41

Are you speaking of transdermal or oral administration of selegiline?

> The problem is (or so I have read) that selegiline at low doses is effective for parkinsons but not for depression. At low doses it is selective for type B MAO sites, but above 10 mg, it is not selective and acts also on type A MAO sites in the body, including the gastrointestinal system. But supposedly the selectivity is very dose dependent and tyramine intake is only considered safe when taking it at 10 mg or less, but at these doses, it hasn't been found to do much for depression.
>
> I think there is also the risk of serotonin syndrome if combining with other meds.

 

Re: Selegiline » mrporter1

Posted by noa on February 23, 2004, at 20:08:16

In reply to Re: NEWS ON THE SELEGILINE PATCH!!!!!!!!!!!!!!!!!!!!!! » noa, posted by mrporter1 on February 22, 2004, at 14:49:07

I was talking about oral selegiline in terms of the food interactions, but about the interaction with other drugs in terms of serotonin levels, it is a question mark for me. IE, the patch would presumably side step the food issue, but I doubt it would change the issue of serotonin interactions.

And I was also presuming that the dose and type of MAO sites affected would be the same for both, which could reflect different levels of effectiveness in treating depression.

Bear in mind, this is conjecture on my part! Hopefully, one of our resident scientists will step in and help us out here!


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